Robotic Versus Video-assisted Lobectomy/Segmentectomy for Lung Surgery

Not Applicable

Recruiting

• Conditions: Lung Diseases; Surgery
• Interventions: Procedure: uniport surgery; Procedure: robotic surgery; Procedure: multiple- port surgery

• Registration Number: NCT05270616
• Lead Sponsor: The Second Hospital of Shandong University

Brief Summary

To compare the safety/efficacy of the robotic-assisted lobectomy/segmentectomy (RAL/S) with the video-assisted lobectomy/segmentectomy (VAL/S) for lung resection.

Video-assisted lobectomy/segmentectomy (VAL/S) for lung resection is divided into uniport group and multiple- port group.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-27
• Study First Submitted QC: 2022-02-27
• Last Update Submitted: 2022-02-27
• Study First Posted: 2022-03-08
• Last Update Posted: 2022-03-08
• Primary Completion: 2023-06-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1. good cardio- pulmonary function to tolerate surgery;
2. minimaly invasive surgery for lobectomy or segmentectomy or sleeve lobectomy;

Exclusion Criteria

1. cardio- pulmonary function is not good enough to tolerate surgery;
2. huge tumor or extensive adhesion in thoracic cavity.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
uniport surgery group	uniport surgery	VATS minimally invasive lung surgery under the uniportal status.
robotic surgery group	robotic surgery	minimally invasive lung surgery using the Davinci robotic system to assist.
multiple- port surgery group	multiple- port surgery	VATS minimally invasive lung surgery under the multiple- port status.

Primary Outcome Measures

Name	Time	Method
conversion rate to open surgery	during surgery	incidence rate
days to tube removal	within 7 days after surgery	days
mortality	30 days after surgery	incidence rate
retrieved lymph node station	within 1 days after surgery	amount
postoperative complications	within 7 days after surgery	incidence rate
duration of hospitalization	within 7 days after surgery	days
retrieved lymph node	within 1 days after surgery	amount
short- term PFS	3 years	proportion
operation time	within 180 minutes	minutes
short- term overall survival	3 years	proportion

Trial Locations

Locations (1)

The Second Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China